1. (1) Legend drugs dispensed to a patient except controlled substances may be donated by the patient or, if the patient is deceased or incompetent, the patient's spouse, an adult child, a brother or sister, either parent, a legally-appointed guardian, or the administrator of the estate of a deceased patient.

2. (2) The physician or pharmacist associated with the charitable clinic shall ensure that the drugs that are accepted for use by the charitable clinic meet the following criteria:

   1. (a) The drugs are no longer needed by the original patient due to death or a stop order by the patient’s physician.
   2. (b) The drugs have been maintained in accordance with the United States Pharmacopeia and National Formulary storage requirements.
   3. (c) The drugs were originally dispensed by unit dose or an individually sealed dose and they are still intact in the original dispensed container. Medications in a bulk container are only acceptable from a hospice program.
   4. (d) The drugs have not expired. The drugs must be used prior to the expiration date on the package.

Author: Charles C. Thomas, R.Ph., FAPhA, State Pharmacy Director

Statutory Authority: Act No. 2002-498.

History: New Rule: Filed May 20, 2003; effective June 24, 2003.